1). Field of the Invention
This invention relates to packaging of catheter products.
2). Discussion of Related Art
Catheter products are increasingly used for gaining entry into internal target sites, for example for gaining entry into a lumen or other vascular of a person, and for passing diagnostic, therapeutic or other agents into or removing fluids from the internal target sites.
A catheter product of this kind usually includes a body, and an elongate vascular access member having a first end secured to the body and a second end located distant from the body. The second end is inserted into a lumen or other vascular. Many catheter products have needles located in their vascular access members, the needles having sharp tips which are used for piercing a required area for purposes of gaining entry. On other catheter products the vascular access members themselves are needles which have second ends which are sharpened for purposes of gaining entry. Once entry is gained into a required internal target site, fluids can be passed through the vascular access member and the body to or from the internal target sites.
A catheter product is usually packaged by first inserting the vascular access member thereof through an opening in a sheath, followed by the body thereof. The body is then secured to the sheath so that the catheter product is located in a stationary position relative to sheath with the second end of the vascular access member located distant from an inner wall of the sheath. The sheath then provides the necessary structure to protect the vascular access member.
Once the catheter product is secured to the sheath, a portion of the body of the catheter product still protrudes from the opening in the sheath, thus potentially exposing the portion of the body protruding from the opening in the sheath to contamination. An interface between the body and the sheath is also usually not of the kind which prevents ingress of contaminants into that the sheath, thus potentially exposing the remainder of the catheter product, including the vascular access member, to contamination.
To prevent contamination, the sheath and the catheter product are subsequently loosely located within conventional blister packaging. The blister packaging provides an enclosure which is sealed against ingress of contaminants and prevents contamination of the sheath and catheter product. The catheter product, in effect, therefore has to be packaged twice, once to provide the required structural integrity to protect the vascular access member, and once more to prevent contamination.
According to one aspect of the invention, a medical package is provided which includes a housing, and a catheter product. The housing defines an enclosure which is sealed against ingress of contaminants. The housing has at least a first part and a second part which is movable relative to the first part to open the enclosure. At least one of the parts has a plurality of pores through which a sterilization fluid can enter the enclosure, but which substantially prevent entry of contaminants into the enclosure. The catheter product includes a body, and a vascular access member. The vascular access member has a first end and a second, vascular entry end. The first end is secured to the body and the second end is located distant from the body. The catheter product is located entirely within the enclosure. The catheter product is secured in position to the housing. The catheter product is removed from the housing after the second part is moved relative to the first part to open the enclosure.
The first part may be a hollow sheath with an opening providing access into the sheath. The catheter product may be at least partially located within the sheath and be secured to the sheath inside the sheath. The second part maybe a lid which closes the opening.
A lid may be attached to a periphery of the opening and the attachment between the lid and the periphery of the opening may be at least partially breakable.
The enclosure, formed by the sheath, may be relatively large in a first area near the opening and relatively small in a second area on a side of the first area opposing the opening. The body may be secured to the sheath in the first area, and the elongate needle member may be at least partially located in the second area.
The sheath may have a retaining formation extending from an inner surface thereof, and the body may have an engaging formation which engages with the retaining formation to support the catheter product in position.
The retaining formation may include first and second projections with a gap defined between them. At least one of the projections may be movable to the extent that it can give way under a force created by the engaging formation when the catheter product is inserted into the sheath, and at least partially return to its original position so as to lock the engaging formation in the gap.
The sheath may at least partially be made of a flexible material. The retaining formation may move away from the engaging formation when the sheath is flexed, thereby disengaging the engaging formation from the retaining formation so as to allow for removal of the catheter product from the sheath.
The medical package may include finger tabs on opposing side of the package sheath which, when contacted by two respective fingers on a hand of a person, and are moved relative to one another by the fingers, may cause movement of the retaining formation away from the engaging formation and disengagement of the engaging formation from the retaining formation.
The retaining formation may extend in a first selected direction from the inner surface. When the finger tabs are moved relative to one another, the sheath may be squeezed together transversely to the first selected direction, causing the retaining formation to move away from the engaging formation in a second selected direction, opposing the first selected direction, and disengagement of the engaging formation from the retaining formation.
The medical package may include flange portions extending from the sheath, and the finger tabs may be located on the flange portions.
The flange portions may pivot about first portions of the sheath and compress second portions of the sheath towards one another to cause elongation of at least part of the sheath in the second selected direction.
At least a first of the finger tabs may pivot about a first portion of the sheath, and the retaining formation may be located on a second portion of the sheath, and a side of the first portion approximately opposing the first finger tab, so that, when the first finger tab pivots about the first portion in a first pivoting direction, the retaining formation also pivots in the first pivoting direction about the first portion away from the engaging formation.
The sheath may include an additional retaining formation which engages with a retaining formation of the sheath. A second of the finger tabs may pivot about a third portion of the sheath. The additional retaining formation may be located on a fourth portion of the sheath on a side of the third portion approximately opposing the second finger tabs so that, when the second finger tab pivots about the third portion in a second pivoting direction, opposing the first pivoting direction, the additional retaining formation also pivots in the second direction away from the additional engaging formation.
The sheath may have a hinge portion between the retaining formations which, when the first finger tab pivots in the first pivoting direction and the second finger tab pivots in the second pivoting direction, assists in increasing an amount of rotation of the retaining formations relative to one another, resulting in more movement of the respective retaining formations away from the respective engaging formations.
The hinge portion may be formed so as to create a stress concentration which causes more flexing of the sheath.
The hinge portion may be a narrowing in the sheath.
The sheath may have at least first and second components. When the lid is at least partially removed, the second component may be movable relative to the first component to allow for better access to the medical product.
The retaining formation may be located on an inner wall of the sheath, and the body may have an engaging formation which engages with the first component. When the second component is moved relative to the first component to allow for better access to the medical product, the engaging formation may be engaged with the retaining formation.
The second component may hinge relative to the first component.
The sheath may have at least a third component which hinges relative to the first component to allow for better access to the medical product.
The opening may have at least two finger wells, on different sides of the catheter product. Fingers on a hand of a person may be insertable into the finger wells. The finger wells may be open towards the catheter product to allow for gripping of the catheter product and subsequent removal of the catheter product from the sheath.
The sheath may have first and second opposed wall portions having edges which partially define the opening, and the lid closing off the opening, wherein the edges are shaped so that, when the lid is at least partially moved to open the enclosure, there is a line of sight through the sheath between the wall portions of the sheath, the line of sight being at least partially blocked by the catheter product.
The opening may be formed so that, when the lid is at least partially moved to open the enclosure, a portion of the medical product may be exposed when viewed in a direction at right angles to a center line of the medical product.
The second end is preferably displaced from an inner wall of the housing.
A sharp tip is preferably located at the second end.
The vascular access member is preferably a needle and the second end is a sharp tip of the needle. The medical package may further include a catheter assembly which includes a hollow hub and a catheter. The catheter has a first end secured to the hub and a second end located distant from the hub. The hub and catheter are located over the needle with the catheter located on a side of the hub opposing the body. The housing may have a shelf on an inner surface thereof which supports the hub on a surface thereof opposing the body.
The invention also provides a medical package which includes a housing and a catheter product. The housing defines an enclosure which is sealed against ingress of contaminants. The housing has a hollow elongate sheath with an end having an opening into the sheath. The lid closes the opening and seals with a periphery of the opening. The catheter product includes a body, and a vascular access member. The vascular access member has a first end and a second, vascular entry end. The first end is secured to the body and the second end is located distant from the body. The catheter product is located entirely within the sheath.
The invention also provides a method of packaging a catheter product. The catheter product is located within a housing. The housing defines an enclosure which is sealed against ingress of contaminants and has at least one part having a plurality of pores through which a sterilization fluid can enter the enclosure, but which substantially prevent entry of contaminants into the enclosure. The medical product is located entirely within the enclosure. The medical product has a body secured in position to the housing, and a vascular access member having a first end and second, vascular entry end. The first end is secured to the body and the second end is located distant from the body in a position which is displaced from an inner wall of the housing.